rotavirus vaccine, live, pentavalent

ROE-ta-vye-rus VAX-een lyve, pen-ta-VAY-lent

Commonly used brand name(s)

In the U.S.

• RotaTeq

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

Uses For rotavirus vaccine, live, pentavalent

Rotavirus vaccine live pentavalent is used to prevent infants and children from getting a rotavirus stomach infection. It works by causing your child's body to produce its own protection (antibodies) against the virus.

Rotavirus is a serious infection that causes diarrhea and vomiting. This infection may also lead to severe dehydration in infants and children.

This vaccine is to be administered only by or under the supervision of your child's doctor or other health care professional.

Before Using rotavirus vaccine, live, pentavalent

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rotavirus vaccine, live, pentavalent or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rotavirus vaccine live pentavalent in infants younger than 6 weeks of age or older than 32 weeks of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of rotavirus vaccine live pentavalent in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

• Aclarubicin


• Aldesleukin


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Betamethasone


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Chlorambucil


• Cisplatin


• Cladribine


• Corticotropin


• Cortisone


• Cosyntropin


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Deflazacort


• Dexamethasone


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etoposide


• Floxuridine


• Fludarabine


• Fludrocortisone


• Fluocortolone


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Hydrocortisone


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Interferon Alfa


• Interferon Alfacon-1


• Interferon Beta


• Interferon Beta-1a


• Interferon Beta-1b


• Interferon Gamma


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Mercaptopurine


• Methotrexate


• Methylprednisolone


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Oxaliplatin


• Paclitaxel


• Paclitaxel Protein-Bound


• Paramethasone


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Prednisolone


• Prednisone


• Procarbazine


• Raltitrexed


• Rituximab


• Streptozocin


• Teceleukin


• Tegafur


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Triamcinolone


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aclarubicin


• Adalimumab


• Aldesleukin


• Alemtuzumab


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Azathioprine


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Everolimus


• Fingolimod


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Mercaptopurine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Sirolimus


• Streptozocin


• Tacrolimus


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Ustekinumab


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Leflunomide


• Vaccinia Immune Globulin, Human

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disorders (e.g., leukemia, lymphoma) or


• Receiving immunosuppressive treatment (e.g., corticosteroids) or


• Weakened immune system (e.g., HIV or AIDS)—There is no evidence that this vaccine is safe or effective in infants with these conditions.

• Chronic diarrhea or


• Digestive problems (e.g., abdominal or stomach surgery, active stomach illness) or


• Failure to thrive (poor weight gain and physical growth failure)—Use with caution. There is no evidence that this vaccine is safe or effective in infants with these conditions.

• Illness with fever, moderate or severe—Your child may need to wait until he or she feels better before receiving the vaccine.

• Severe combined immunodeficiency disease or SCID (an inherited disease), history of—Should not be used in patients with this condition.

Proper Use of rotavirus vaccine, live, pentavalent

A nurse or other trained health professional will give your child this vaccine. It is given by mouth.

rotavirus vaccine, live, pentavalent needs to be given on a fixed schedule. If your child missed the scheduled dose, call your child’s doctor for another appointment.

rotavirus vaccine, live, pentavalent comes with a patient information leaflet. Read the information carefully. Ask your child's doctor if you have any questions.

Dosing

The dose of rotavirus vaccine, live, pentavalent will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of rotavirus vaccine, live, pentavalent. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (solution):
  
  • To prevent rotavirus infection:
    
    • Infants and children 32 weeks (8 months) of age and older—Use and dose must be determined by your doctor.
    
    
    • Infants 6 weeks of age to 32 weeks of age—The first dose should be given when your child is 6 to 12 weeks of age. The second dose should be given 4 to 10 weeks later, and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks (8 months) of age.
    
    
    • Infants younger than 6 weeks of age—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using rotavirus vaccine, live, pentavalent

It is very important that your child return to your doctor's office at the right time for his or her next dose of this vaccine. Be sure to notify your child's doctor of any side effects that occur after your child receive this vaccine.

Make sure your child's doctor knows if your child has any type of cancer or is receiving a treatment that may weaken the immune system (steroid medicine, radiation treatment, or medicine to treat cancer). Tell you child's doctor if your child has received a blood transfusion or blood products within the past 42 days.

Tell your child's doctor if your child spends time with a person who has immune system problems or is receiving cancer treatment. Your doctor may recommend ways (e.g., proper hand washing after changing of diapers) to help prevent the spread of vaccine virus to other people.

Call your child's doctor right away if your child has diarrhea, blood in the stool, a high fever, severe stomach pain, or vomiting. These maybe symptoms of a serious bowel problem called intussusception.

rotavirus vaccine, live, pentavalent Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Diarrhea


• earache


• fever


• headache


• irritability


• muscle aches


• sore throat


• stuffy or runny nose


• unusual tiredness or weakness


• vomiting

Less common

• Cough


• difficulty with breathing


• noisy breathing


• shortness of breath


• tightness in the chest


• wheezing

Rare

• Black, tarry stools


• seizures

Incidence not known

• Nausea


• pain or cramping in the abdomen or stomach

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Irritability

Incidence not known

• Hives or welts


• itching


• redness of the skin


• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More rotavirus vaccine, live, pentavalent resources

• Rotavirus vaccine, live, pentavalent Use in Pregnancy & Breastfeeding
• Rotavirus vaccine, live, pentavalent Drug Interactions
• Rotavirus vaccine, live, pentavalent Support Group
• 0 Reviews for Rotavirus vaccine, live, pentavalent - Add your own review/rating

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Reyataz

Pronunciation: A-ta-ZAN-a-vir
Generic Name: Atazanavir
Brand Name: Reyataz

Taking Reyataz with other medicines may result in serious or life-threatening side effects. Ask your doctor or pharmacist if you have any questions about which medicines should not be taken with Reyataz.

Reyataz is used for:

Treating HIV infection along with other medicines.

Reyataz is an HIV protease inhibitor. It works by inhibiting HIV protease, which is the enzyme required to form functional proteins in HIV-infected cells.

Do NOT use Reyataz if:

• you are allergic to any ingredient in Reyataz


• you are taking alfuzosin, certain benzodiazepines (eg, oral midazolam, triazolam), cisapride, an ergot derivative (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), indinavir, irinotecan, nevirapine, pimozide, rifampin, salmeterol, or St. John's wort


• you are taking sildenafil for pulmonary arterial hypertension (PAH)


• you are taking voriconazole and you take ritonavir along with Reyataz


• you are taking bosentan (unless you also take ritonavir along with Reyataz)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Reyataz:

Some medical conditions may interact with Reyataz. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a blood disorder (eg, hemophilia), diabetes, heart problems (eg, atrioventricular block), or liver problems (including hepatitis B or hepatitis C)


• if you have kidney problems or are on dialysis

Some MEDICINES MAY INTERACT with Reyataz. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Certain benzodiazepines (eg, oral midazolam, triazolam), cisapride, ergot derivatives (eg, ergotamine), pimozide, or salmeterol because serious side effects, such as breathing problems, blood vessel problems, or irregular heartbeat, may occur


• Certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin) because the risk of serious muscle effects may be increased


• Alfuzosin because the risk of severe low blood pressure may be increased


• Indinavir because it may increase the risk of Reyataz's side effects


• Bosentan (unless you also take ritonavir with Reyataz), nevirapine, rifampin or, St. John's wort because they may decrease Reyataz's effectiveness


• Irinotecan or sildenafil (when used for PAH) because the risk of its side effects may be increased by Reyataz


• Voriconazole (if you take ritonavir along with Reyataz) because its effectiveness may be decreased


• Many prescription and nonprescription medicines (eg, used for aches and pains, angina, asthma, birth control, blood pressure, blood thinning, cancer, depression, erectile dysfunction, heartburn or reflux disease, gout, immune system suppression, infections, inflammation, irregular heartbeat, heart problems, high blood pressure, high cholesterol, HIV, mental or mood problems, migraine, opioid addiction, pain, PAH, overactive bladder, seizures, sleep aid), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Reyataz, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Reyataz may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Reyataz:

Use Reyataz as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Reyataz. Talk to your pharmacist if you have questions about this information.


• Take Reyataz by mouth with food.


• Swallow Reyataz whole. Do not break, crush, or chew before swallowing.


• Take Reyataz on a regular schedule to get the most benefit from it.


• Taking Reyataz at the same time each day will help you remember to take it.


• If you also take a proton pump inhibitor (eg, omeprazole), take it about 12 hours before you take Reyataz.


• If you also take an H₂ antagonist (eg, cimetidine), talk with your doctor about how to take it with Reyataz.


• If you also take an antacid or didanosine, take Reyataz at least 2 hours before or 1 hour after the antacid or didanosine.


• Continue to use Reyataz even if you feel well. Do not miss any doses.


• If you miss a dose of Reyataz, take it as soon as possible. If it is within 6 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Reyataz.

Important safety information:

• Reyataz may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Reyataz with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Reyataz is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Reyataz, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Reyataz does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Reyataz. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Reyataz. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Reyataz may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of an infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Reyataz.


• Reyataz may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Reyataz may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including liver function, bilirubin levels, lipid or cholesterol levels, and electrocardiograms, may be performed while you use Reyataz. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Reyataz with caution in the ELDERLY; they may be more sensitive to its effects.


• Reyataz should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• Reyataz should not be used in CHILDREN younger than 3 months old; a type of brain damage caused by high blood bilirubin levels (kernicterus) may occur.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Reyataz while you are pregnant. It is not known if Reyataz is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Reyataz to the baby.

Possible side effects of Reyataz:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in body fat; cough; diarrhea; fatigue; headache; increased cough; muscle pain; nausea; pain; stomach pain; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; chest pain; dizziness; fever, chills, or sore throat; increased urination or thirst; irregular heartbeat; lightheadedness; mental or mood changes (eg, depression); numbness, tingling, or extreme weakness especially in the arms or legs; painful urination; red, blistered, or swollen skin; severe nausea or vomiting; severe stomach or side pain; trouble breathing; unusual bleeding or bruising; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Reyataz side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe dizziness and lightheadedness; yellowing of the eyes or skin.

Proper storage of Reyataz:

Store Reyataz at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Reyataz out of the reach of children and away from pets.

General information:

• If you have any questions about Reyataz, please talk with your doctor, pharmacist, or other health care provider.


• Reyataz is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Reyataz. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Reyataz resources

• Reyataz Side Effects (in more detail)
• Reyataz Use in Pregnancy & Breastfeeding
• Drug Images
• Reyataz Drug Interactions
• Reyataz Support Group
• 1 Review for Reyataz - Add your own review/rating

• Reyataz Prescribing Information (FDA)


• Reyataz Monograph (AHFS DI)


• Reyataz Advanced Consumer (Micromedex) - Includes Dosage Information


• Reyataz Consumer Overview

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In the US, Tessalon (benzonatate systemic) is a member of the drug class antitussives and is used to treat Cough.

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Benzonatate

Benzonatate is reported as an ingredient of Tessalon in the following countries:

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Tamsulosin Stada retard

Tamsulosin Stada retard may be available in the countries listed below.

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Tamsulosin

Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsulosin Stada retard in the following countries:

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Felbinac

Felbinac is reported as an ingredient of Napageln in the following countries:

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Rizatriptan Benzoate

Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: N,N-Dimethyl-5-(1H-1,2,4-triazol-1-yl-methyl)-1H-indole-3-ethanamine monobenzoate
Molecular Formula: C₁₅H₁₉N₅•C₇H₆O₂
CAS Number: 145202-66-0
Brands: Maxalt

Introduction

Selective serotonin (5-hydroxytryptamine; 5-HT) type 1B and 1D receptor agonist (“triptan”).^{1 2 3 21}

Uses for Rizatriptan Benzoate

Vascular Headaches

Acute treatment of migraine attacks with or without aura.^{1 12 13}

Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine.¹

Safety and efficacy not established for management of cluster headaches.¹

Rizatriptan Benzoate Dosage and Administration

Administration

Oral Administration

Administer orally as conventional or orally disintegrating tablets without regard to meals.¹

Just prior to administration of orally disintegrating tablet, remove blister from aluminum pouch; with dry hands, peel open blister package, place tablet on tongue to dissolve, and swallow with saliva.¹

Administration of orally disintegrating tablet with liquid is not necessary.¹

Dosage

Available as rizatriptan benzoate; dosage is expressed in terms of rizatriptan.¹

Adults

Vascular Headaches

Migraine

Oral

5 or 10 mg as a single dose;¹ individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 10-mg dose.¹

Additional doses may be administered at intervals of ≥2 hours, up to a maximum dosage of 30 mg in any 24-hour period.¹

Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.¹

Prescribing Limits

Adults

Vascular Headaches

Migraine

Oral

Maximum 30 mg in any 24-hour period.¹

Safety of treating an average of >4 headaches per 30-day period has not been established.¹

Cautions for Rizatriptan Benzoate

Contraindications

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  Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).¹

  
  


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  Coronary artery vasospasm (e.g., Prinzmetal variant angina).¹

  
  


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  Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).¹

  
  


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  Hemiplegic or basilar migraine.¹

  
  


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  Treatment within previous 24 hours with another 5-HT₁ agonist or an ergot alkaloid.¹ (See Specific Drugs under Interactions.)

  
  


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  Concurrent or recent (within 2 weeks) treatment with an MAO inhibitor.¹ (See Specific Drugs under Interactions.)

  
  


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  Known hypersensitivity to rizatriptan or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Use only in patients in whom a clear diagnosis of migraine has been established.¹

Exclude other potentially serious neurologic disorders before administering rizatriptan to patients not previously diagnosed with migraine or to those with atypical symptoms.¹⁴

Cardiac Effects

Possible myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbances, and death.¹

Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.¹

Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.¹

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.¹

Patients with symptoms suggestive of angina after receiving rizatriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses; if administration resumed and such signs or symptoms recur, ECG evaluation recommended.¹

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal.¹

Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.¹

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT₁ receptor agonists.¹ Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic colitis, Raynaud’s phenomenon) occur following administration.¹

Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT₁ receptor agonists in patients with or without history of hypertension.¹

Increases in mean pulmonary artery pressure observed following administration of a 5-HT₁ receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.^{1 14}

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT₁ receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs).^{1 20} Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).^{1 20}

General Precautions

Ocular Effects

Possible accumulation of rizatriptan in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.¹

Phenylketonuria

Advise individuals who must restrict phenylalanine intake that each 5- or 10-mg Maxalt-MLT orally disintegrating tablet contains aspartame, which is metabolized in GI tract to provide 1.05 or 2.1 mg of phenylalanine, respectively.¹ Conventional tablets do not contain aspartame.¹

Specific Populations

Pregnancy

Category C.¹ Pregnancy Registry at 800-986-8999.¹⁸

Lactation

Distributed into milk in rats; not known whether distributed into milk in humans.¹ Caution advised if rizatriptan is used.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.¹

Geriatric Use

No substantial differences in efficacy, safety, or pharmacokinetic profile relative to younger adults; however, limited clinical experience in patients ≥65 years of age.¹

Hepatic Impairment

Use with caution in patients with moderate hepatic impairment.¹ (See Special Populations under Pharmacokinetics.)

Not studied in patients with severe hepatic impairment.¹⁷

Renal Impairment

Use with caution in patients undergoing dialysis.¹ (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Pain/pressure sensations (i.e., chest pain [tightness/pressure/heaviness], pain/tightness/pressure in neck/throat/jaw, regional pain [tightness/pressure/heaviness], pain at location not specified),¹ asthenia/fatigue,^{1 4} dizziness,^{1 4} somnolence,^{1 4} dry mouth,^{1 4} nausea,^{1 4} paresthesia.^{1 4}

Interactions for Rizatriptan Benzoate

Metabolized by MAO-A.¹⁸

Does not inhibit CYP3A4/5, 1A2, 2C9, 2C19, or 2E1; inhibits CYP2D6 only at high concentrations.¹⁸

Specific Drugs

Drug	Interaction	Comments
Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine)	Potentially life-threatening serotonin syndrome1 20 Study in healthy individuals showed no effect of paroxetine on plasma concentrations or safety profile of rizatriptan1 15	Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated1 20
β-Adrenergic blocking agents (metoprolol, nadolol, propranolol)	No pharmacokinetic interaction observed with metoprolol or nadolol1 22 Propranolol increased plasma rizatriptan concentrations in one study 1	If used concomitantly with metoprolol or nadolol, no dosage adjustment required1 22 If used concomitantly with propranolol, maximum rizatriptan dosage of 5 mg per single dose and 3 doses per 24-hour period recommended1
Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide)	Additive vasospastic effects1	Use within 24 hours contraindicated1
5-HT1 receptor agonists	Additive vasospastic effects1	Use within 24 hours contraindicated1
MAO inhibitors	Increased systemic exposure to rizatriptan and active N-monodesmethyl metabolite1 16	Use within 2 weeks of MAO inhibitor contraindicated1
Oral contraceptives	Pharmacokinetic interaction unlikely1 23

Rizatriptan Benzoate Pharmacokinetics

Absorption

Bioavailability

Completely absorbed from GI tract, ^{1 2} but absolute bioavailability (as conventional tablet) is 45%,¹ indicating first-pass metabolism.^{1 2} Bioavailability is similar for orally disintegrating tablets.¹

Peak plasma concentrations attained within 1–1.5 hours (conventional tablets) or 1.6–2.5 hours (orally disintegrating tablets) after oral administration.¹

AUC and peak plasma concentration are approximately 30 and 11% higher, respectively, in females than in males.¹

Food

Food does not substantially affect bioavailability but may delay time to peak concentration by 1 hour.¹

Distribution

Extent

Crosses placenta and is distributed into milk in animals; no studies in pregnant or nursing women.¹

Plasma Protein Binding

14%.¹

Elimination

Metabolism

Metabolized principally via oxidative deamination by MAO-A to an inactive indole acetic acid metabolite.¹⁸ Other minor metabolites, including an N-monodesmethyl derivative with similar activity to the parent compound, have been identified.¹⁸

Elimination Route

Excreted principally in urine (14% of dose as unchanged drug, 51% as indole acetic acid metabolite).^{18 19}

Half-life

Approximately 2–3 hours.¹⁸

Special Populations

In patients with moderate hepatic impairment, plasma rizatriptan concentrations are approximately 30% higher than in healthy individuals.¹⁸

In hemodialysis patients, AUC is approximately 44% greater than in patients with normal renal function.¹⁸

Stability

Storage

Oral

Tablets

Tight containers at 15–30°C.¹⁸

Orally Disintegrating Tablets

15–30°C.¹⁸

ActionsActions

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  Binds with high affinity to 5-HT_1B and 5-HT_1D receptors.^{1 2 3 21}

  
  


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  Structurally and pharmacologically related to other selective 5-HT_1B/1D receptor agonists (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, zolmitriptan).^{1 2 21}

  
  


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  Precise mechanism of action not established;^{1 2 3} may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathway.^{1 2 21}

  
  

Advice to Patients

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  Importance of immediately informing clinician if tightness, pain, pressure, or heaviness in chest, throat, neck, or jaw occurs and of not taking rizatriptan again until evaluated by clinician.¹

  
  


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  Importance of taking rizatriptan exactly as prescribed.¹

  
  


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  Importance of providing patient a copy of manufacturer’s patient information.¹

  
  


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  Risk of dizziness, somnolence, and fatigue; importance of exercising caution when driving or operating machinery.¹

  
  


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  For patients taking orally disintegrating tablets, importance of not removing the blister from the outer pouch until just before administering dose; importance of opening blister pack with dry hands and of placing tablet on tongue to dissolve and be swallowed with saliva.¹

  
  


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  Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame.¹

  
  


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  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).¹

  
  


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  Importance of informing patients of risk of serotonin syndrome with concurrent use of rizatriptan and an SSRI or SNRI.^{1 20} Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.^{1 20}

  
  


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  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


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  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Rizatriptan Benzoate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	5 mg (of rizatriptan)	Maxalt	Merck
		10 mg (of rizatriptan)	Maxalt	Merck
	Tablets, orally disintegrating	5 mg (of rizatriptan)	Maxalt-MLT (with aspartame)	Merck
		10 mg (of rizatriptan)	Maxalt-MLT (with aspartame)	Merck

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Maxalt 5MG Tablets (MERCK SHARP &amp; DOHME): 12/$325.99 or 24/$634.99

Maxalt-MLT 10MG Dispersible Tablets (MERCK SHARP &amp; DOHME): 6/$165.99 or 18/$475.98

Maxalt-MLT 5MG Dispersible Tablets (MERCK SHARP &amp; DOHME): 3/$290.99 or 9/$851.96

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Merck and Co., Inc. Maxalt (rizatriptan benzoate) tablets and Maxalt-MLT (rizatriptan benzoate) orally disintegrating tablets prescribing information. Whitehouse Station, NJ; 2006 Jun.

2. Goadsby PJ, Hargreaves RJ. Mechanisms of action of serotonin 5-HT_1B/1D agonists: insights into migraine pathophysiology using rizatriptan. Neurology. 2000; 55(Suppl 2):S8-S14. [IDIS 455607] [PubMed 11089513]

3. Dooley M, Faulds D. Rizatriptan: a review of its efficacy in the management of migraine. Drugs. 1999; 58:699-723. [PubMed 10551439]

4. Kramer MS, Matzura-Wolfe D, Polis A et al. A placebo-controlled crossover study of rizatriptan in the treatment of multiple migraine attacks. Neurology. 1998; 51:773-81. [IDIS 414343] [PubMed 9748025]

5. Tfelt-Hansen P, Teall J, Rodriguez F et al. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Headache. 1998; 38:748-55. [PubMed 11284463]

6. Teall J, Tuchman M, Cutler N et al. Rizatriptan (Maxalt) for the acute treatment of migraine and migraine recurrence. Headache. 1998; 38:281-7. [PubMed 9595867]

7. Lines C, Visser WH, Vandormael K et al. Rizatriptan 5 mg versus sumatriptan 50 mg in the acute treatment of migraine. Headache. 1997; 37:319-20.

8. Ahrens SP, Farmer MV, Williams DL et al. Efficacy and safety of rizatriptan wafer for the acute treatment of migraine. Cephalagia. 1999; 19:525-30.

9. Dahlof CGH, Rapoport AM, Sheftell FD et al. Rizatriptan in the treatment of migraine. Clin Ther. 1999; 21:1823-6. [IDIS 440855] [PubMed 10890255]

10. Block GA, Goldstein J, Polis A et al. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Headache. 1998; 38:764-71. [PubMed 11284464]

11. Goldstein J, Ryan R, Jiang K et al. Crossover comparison of rizatriptan 5 mg and 10 mg versus sumatriptan 25 and 50 mg in migraine. Headache. 1998; 38:737-47. [PubMed 11284462]

12. Matchar DB, Young WB, Rosenberg JH et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. From American Academy of Neurology web site (http://www.aan.com).

13. Silberstein SD, for the US Headache Consortium. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the quality standards subcommittee of the American Academy of Neurology. Neurology. 2000; 55:754-63. [IDIS 453389] [PubMed 10993991]

14. Glaxo Wellcome Inc. Amerge (naratriptan hydrochloride) tablets prescribing information. Research Triangle Park, NC; 1999 Nov.

15. Goldberg MR, Lowry RC, Musson DG et al. Lack of pharmacokinetic and pharmacodynamic interaction between rizatriptan and paroxetine. J Clin Pharmacol. 1999; 39:192-99. [IDIS 422446] [PubMed 11563413]

16. van Haarst AD, van Gerven JMA, Cohen AF et al. The effects of moclobemide on the pharmacokinetics of the 5-HT_1B/1D agonist rizatriptan in healthy volunteers. Br J Clin Pharmacol. 1999; 48:190-6. [IDIS 432034] [PubMed 10417495]

17. Merck, West Point, PA: Personal communication.

18. Merck & Co., Inc. Maxalt (rizatriptan benzoate) tablets/Maxalt-MLT (rizatriptan benzoate) orally disintegrating tablets, prescribing information. Whitehouse Station, NJ; 2001 Oct.

19. Vyas KP, Halpin RA, Geer LA et al. Disposition and pharmacokinetics of the antimigraine drug, rizatriptan, in humans. Drug Metab Dispos. 2000; 28:89-95. [IDIS 441742] [PubMed 10611145]

20. Food and Drug Administration. Public health advisory: combined use of 5-hydroxytryptamine receptor agonists (triptans), selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephirne reuptake inhibitors (SNRIs) may result in life-threatening serotonin syndrome. Rockville, MD; 2006 Jul 19. From the FDA website: ( and ).

21. Tfelt-Hansen P, De Vries P, Saxena PR. Triptans in migraine: a comparative review of pharmacology, pharmacokinetics and efficacy. Drugs. 2000; 60:1259-87. [PubMed 11152011]

22. Goldberg MR, Sciberras D, De Smet M et al. Influence of beta-adrenoceptor antgaonists on the pharmacokinetics of rizatriptan, a 5HT1B/1D agonist: differential effects of propranolol, nadolol and metoprolol. Br J Clin Pharmacol. 2001; 52:69-76. [PubMed 11453892]

23. Shadle CR, Liu G, Goldberg MR. A double-blind, placebo-controlled evaluation of the effect of oral doses of rizatriptan 10 mg on oral contraceptive pharmacokinetics in healthy female volunteers. J Clin Pharmacol. 2000; 40:309-15. [PubMed 10709161]

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